NCT00098774 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16 Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
- id
- FG000
- title
- Intensive Combination Chemo & Immunotherapy
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 9
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Failed (to respond) during induction
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 44
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 18
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Three participants were excluded from analysis because of failure to meet eligibility criteria or to receive protocol therapy.
- recruitment Details
- Between October 2004 and November 2009, 47 participants were recruited at 12 CALGB sites.
Complete source fields
- groups
- description
- Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16 Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
- id
- FG000
- title
- Intensive Combination Chemo & Immunotherapy
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 9
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Failed (to respond) during induction
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 44
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 18
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Three participants were excluded from analysis because of failure to meet eligibility criteria or to receive protocol therapy.
- recruitment Details
- Between October 2004 and November 2009, 47 participants were recruited at 12 CALGB sites.
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Preserved source evidence · Not medical advice
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